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Influence of CYP3A4-induction by St. John's Wort on the Steady State Pharmacokinetics of Bosentan

NCT01258504 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 13

Last updated 2017-05-31

Study results available
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Summary

The aim of the present study is to assess the impact of the cytochrome P450 2C9 (CYP2C9) genotype (\*2 and \*3 allele versus wild type; \~3-5% poor metabolisers in Caucasian population) on the pharmacokinetics of bosentan and the impact of CYP3A4-induction by St. John's wort (SJW) on steady state bosentan which is a CYP3A4 inducer itself.

Conditions

  • Drug Interactions

Interventions

DRUG

St. Johns Wort

* Administration of bosentan: 1 x 125 mg p.o. on days 1 and 20, 2 x 62.5 mg p.o. on day 2, 2 x 125 mg p.o. on days 3-19. * Administration of SJW: 3 x 300 mg daily p.o. on days 11-19 and 2 x 300 mg on day 20

Sponsors & Collaborators

  • Gerd Mikus

    lead OTHER

Principal Investigators

  • Gerd Mikus, Prof. Dr. · deputy head of department

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2011-12-31
Completion
2012-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01258504 on ClinicalTrials.gov